Dual opioid pain therapy

a technology of opioid pain and opioids, applied in the direction of biocide, drug composition, dispersed delivery, etc., can solve the problems of many undesirable side effects of the use of opioids, nausea and vomiting, dizziness, constipation, etc., and achieve the effects of reducing the number of side effects of opioid us

Inactive Publication Date: 2009-11-26
QRXPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011]Clearly there is a need for a preferred range of ratios of morphine to oxycodone containing products f

Problems solved by technology

Unfortunately, the effects produced by morphine and similar opioid compounds are associated with many undesirable side effects, all mediated through activation of the mu and other opioid receptors, and make them amenable to abuse.
The undesirable side effects associated with the use of opioids include nausea and vomiting, drowsiness, dizziness, constipation, respiratory depression and bladder dysfunction.
Further a major associated risk is that repeated daily administrations of morphine or morphine-like opioids will eventually induce significant tolerance to the therapeutic effects of the drug, as well as initiating some degree of physical dependence.
Addiction with physical dependence can be difficult to treat due to the effects of withdrawal associated with dependence.
Another undesirable effect of opioid tolerance is that the higher opioid requirements of highly tolerant patients treated for pain increase the likelihood

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0069]Comparison of a Product Containing Morphine and Oxycodone in the Ratio of 3 to 2, Morphine to Oxycodone by Weight vs. Morphine Alone (Study 1) and a Product Containing Morphine and Oxycodone in the Ratio of 1 to 2, Morphine to Oxycodone by Weight vs. Morphine Alone (Study 2) in the Treatment of Chronic Non-Cancer Pain

Study Design

[0070]Both Study 1 and Study 2 were Phase II clinical trials in patients with chronic moderate to severe, non-cancer pain. Both designs were similar, in that they were randomized, double-blind, crossover studies in an inpatient facility for up to a seven day period, for each arm. A standard comparison of each treatment was morphine in both studies. The primary objectives of these protocols were to compare pain relief and safety attributable to either of the two treatment groups. Efficacy was assessed using a Visual Analogue Scale (VAS) pain based on a patient self assessment.

Efficacy

[0071]Study 1 was conducted in 21 patients with chronic non-cancer pai...

example 2

Efficacy and Safety Study of Products Containing Morphine and Oxycodone in a Ratio of 3 to 2 (by Weight) in Acute Pain

Study Design

[0080]This double-blind, ascending cohort, parallel treatment study (Study 3) evaluated analgesia and safety measures in 5 groups of patients with moderate to severe pain (numerical pain rating scale score, range 0-10, study inclusion score of at least 4) following bunionectomy surgery, a procedure that involves manipulation of metatarsal foot bone. Once each of the 256 patients had sufficient pain following surgery, they were randomized to oxycodone / morphine or placebo and received dosing for up to the next 48 hrs. The dosing schedule was flexible in that the inventor wanted to determine what dosing intervals were preferred (and the amount of drug received) by patients as a function of unit dose strengths of products oxycodone and morphine in the ratio of 3 to 2. Dosages administered were 3 / 2 mg, 6 / 4 mg, 12 / 8 mg and 18 / 12 mg or 0 / 0 mg (placebo). Patients...

example 3

[0085]Comparison of a Product Containing Morphine and Oxycodone in the Ratio of 3 to 2 vs. Morphine vs. Oxycodone (Study 4) in the Treatment of Acute Pain

[0086]The purpose of Study 4 was to compare the efficacy and opioid related adverse events of products containing morphine and oxycodone in the ratio of 3 to 2 by weight with its individual components.

Design and Main Measures

[0087]Study 4 was a double-blind, randomized, multicenter, 48 hr treatment duration, bunionectomy study. The fixed dose treatment arms (q6h) were (i) products containing morphine and oxycodone as follows: 12 mg / 8 mg and 6 mg / 4 mg, and (ii) 4 products containing the components alone as follows: morphine 12 mg, morphine 6 mg, oxycodone 8 mg and oxycodone 4 mg. Pain reduction over a 24 hr period (SPID24: area under the curve of the changes in pain from baseline for the 24 hr period following the first dose of study medication) was prospectively defined as the primary endpoint. Also, in this trial ibuprofen rescue ...

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Abstract

Provided are pharmaceutical compositions and methods for the alleviation of pain in a patient with optimal ratios of morphine and oxycodone that provide superior analgesic efficacy and lower incidence of adverse side effects compared to morphine and oxycodone alone. The pharmaceutical compositions comprise morphine and oxycodone, or pharmaceutically acceptable salts thereof, in ratios of about 3 to 2 to about 1 to 2, morphine to oxycodone by weight.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 128,246 filed May 20, 2008, and U.S. Provisional Application No. 61 / 143,863, filed Jan. 12, 2009, both of which are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]This invention is directed to pharmaceutical compositions comprising optimal combinations of morphine and oxycodone that provide synergistic efficacy and lower incidence of undesired side effects for patients undergoing pain therapy. Methods of use comprising administering an effective amount and ratio of the opioid compounds to treat patients suffering from pain are also provided.BACKGROUND OF THE INVENTION[0003]Opioid compounds remain key agents for the treatment of a wide variety of acute and chronic pain. The World Health Organization has recommended morphine as the analgesic of choice for the treatment of severe cancer pain. Additionally, morphine and related opioids a...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61P29/00
CPCA61K9/0095A61K31/485A61K2300/00A61P29/00
Inventor STERN, WARRENPACE, GARY W.IGLESIA, FELIX A. DE LASMITH, MAREERICHARDS, PATRICIA
Owner QRXPHARMA
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